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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.
Industry experts weigh in on best practices, challenges, and mutual recognition of cleaning validation standards.
The landmark decision determined that biosimilar makers can notify manufacturers before receiving FDA approval.
FDA asked Endo Pharmaceuticals to remove Opana ER from the market, citing the potential for abuse.
Amgen filed a complaint against FDA claiming the agency unlawfully denied the company pediatric exclusivity for its secondary hyperparathyroidism treatment Sensipar.